Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000

K-Number: K050309 · 2005-03-25

ApplicantViasys Medsystems
Decision Date2005-03-25
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Medsystems. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K050309. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000?

PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Viasys Medsystems. The 510(k) number is K050309.

When did PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 receive FDA 510(k) clearance?

PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 received FDA 510(k) clearance on 2005-03-25, under 510(k) number K050309.

Who is the listed applicant for PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000?

The FDA 510(k) record lists Viasys Medsystems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000?

The FDA product code for PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 is CAP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Viasys Medsystems as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K081725ENTERAL PUMP SET, MODEL 20-1010K080679MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900K063061CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900K043044ANTI-I.V. ENTERAL FEEDING SYSTEMK043004STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031K041987CORTRAK

View all 7 devices →

Related Devices (Code: CAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑